Kornimate/medical-research-clean huggingface dataset:
efficacy of methyl aminolevulinate + daylight in patients with facial photodamage

Conditions: Facial Photodamage

Summary: treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. this study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage


Eligibility criteria:
inclusion criteria: * adults with symmetric facial photodamage grade 2 or 3 (dover´s scale) * patients willing to participate * signed informed consent exclusion criteria: * pregnant or nursing females * subjects with any photosensitizing disorder * any active infectious skin disorder * history of herpes simplex in the face * subjects with less than 6 months of any previous rejuvenation interfering treatments * history of systemic isotretinoin in the last year * subjects requiring concurrent treatment that would interfere with study objectives and/or assessments * history of hypersensitivity reactions * activities with high sun exposure during 48 hours after treatment * clinical suspicion of any systemic or local malignancy

Keywords: randomized-controlled-trial methyl-aminolevulinate daylight photodynamic-therapy
sitagliptin for hyperglycemia in patients with t2dm undergoing cardiac surgery

Conditions: Hyperglycemia

Summary: the purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (t2d).

the purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) and the need for continuous intravenous insulin infusion (cii) in the intensive care unit (icu) in patients with type 2 diabetes (t2d) undergoing coronary artery bypass graft (cabg) surgery. in addition, the study seeks to determine whether treatment with sitagliptin is effective in maintaining glycemic control and in preventing the need for subcutaneous (sc) insulin therapy in patients with t2d during the transition from intensive care unit (icu) to regular floor in cardiac surgery patients with t2d.

Eligibility criteria:
inclusion criteria: * the ability to provide informed consent * ages 18 to 80 years old * male or female * scheduled to undergo cardiac surgery * type 2 diabetes treated with diet, oral agents, exclusion criteria: * severely impaired kidney function (glomeruler filtration rate (gfr ) less than 30 ml/min) * clinically significant liver failure * imminent risk of death (brain death or cardiac standstill) * gastrointestinal obstruction or adynamic ileus * expected to require gastrointestinal suction * clinically relevant pancreatic or gallbladder disease * using oral or injectable corticosteroid * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * female subjects are pregnant or breast feeding at time of enrollment into the study

Keywords: coronary artery bypass graft surgery (cabg) type 2 diabetes
a research on hidden blood loss in open radical hysterectomy and pelvic lymphadenectomy

Conditions: Hidden Blood Loss; Open Radical Hysterectomy; Cervical Cancer

Summary: the aim of this cross-sectional study is to evaluate the hidden blood loss in patients who underwent open radical hysterectomy and identity its risk factors.

the electronic medical data of 100 patients who undergo open radial hysterectomy in the following year to treat cervical cancer will be analyzed retrospectively in this study. the amount of hidden blood loss will be calculated according to gross's formula. and multiple linear regression analysis will be employed to identify its risk factors.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in the study with informed consent; 2. females aged 20-80 who are confirmed with cervical cancer and are treated with open radical hysterectomy and pelvic lymphadenectomy. exclusion criteria: 1. pregnancy, lactation, postmenopause, or planned pregnancy within two years; 2. suspected or identified as other tumors of genital tract; 3. history of hyperparathyroidism, infectious diseases (tuberculosis, aids), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 4. other diseases or heavy injuries that will interfere with the results; 5. simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
net in iranian women suffering from post traumatic stress symptoms

Conditions: Mental Disorders; Domestic Violence

Summary: the proposed study seeks to investigate to what extent narrative exposure therapy (net) is an effective treatment for the reduction of symptoms of post-traumatic stress disorder (ptsd) and depression and for the improvement of daily functioning in iranian women who have experienced intimate partner violence (ipv). in addition, the study seeks to investigate whether net therapy could lead to the reduction of intimate partner violence (ipv) within their marriage.


Eligibility criteria:
inclusion criteria: * being victims of intimate partner violence and seeking help at target clinics in order to reduce their psychological symptoms, currently living together with their partner/husband, meeting the set cut-off point on the ptsd scale according to dsm-iv. exclusion criteria: * schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment

Keywords: post traumatic stress disorder depression intimate partner violence narrative exposure therapy
effects of pulmonary rehabilitation on functional and health status measures in pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: the inclusion of pulmonary rehabilitation (pr) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. the present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week pr programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis.

the inclusion of pulmonary rehabilitation (pr) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. the present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week pr programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis. this study reports outcomes of an observational, quasi experimental type of study. a total of 120 participants were recruited: 60 patients formed part of the active group, another 60 patients were enrolled in an inactive group. each participant was classified according to the modified medical research council dyspnoea scale and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities. the following outcomes were measured: lung function tests including plethysmography and diffusion capacity of carbon monoxide (dlco), functional tests (6-minute walking test, dyspnoea borg scale) and health status measures (st george's respiratory questionnaire and had score).

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of pulmonary fibrosis * patients had to be medically stable to participate in such a programme exclusion criteria: * any orthopaedic or neurological condition affecting mobility * if they required oxygen therapy this had to be used

Keywords: pulmonary rehabilitation functional outcomes health status exercise
spirit 1: efficacy and safety study of relugolix in women with endometriosis-associated pain

Conditions: Endometriosis Related Pain

Summary: the purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (e2) and norethindrone acetate (neta) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

this study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered with either 12 or 24 weeks of low-dose e2 (1.0 mg) and neta (0.5 mg), compared with placebo. approximately 600 women with endometriosis-associated pain will be enrolled and randomized 1:1:1 to group a - relugolix plus low-dose hormonal add-back therapy, group b - relugolix monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back therapy, or group c - placebo (n = 200 per group). eligible participants were randomized on baseline day 1 to treatment group a, b, or c, in the double-blind period. eligible participants, including those randomized to placebo, were offered the opportunity to enroll in an 80-week open-label extension study where participants received relugolix co-administered with low-dose e2 and neta. participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the participant's last dose of study drug.

Eligibility criteria:
key inclusion criteria: 1. is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form. 2. has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these. 3. has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy. 4. during the run-in period (35 to 70 days prior to treatment period) has a dysmenorrhea nrs score ≥ 4.0 on at least 2 days and 1. mean nmpp nrs score ≥ 2.5, or 2. mean nmpp nrs score ≥ 1.25 and nmpp nrs score ≥ 5.0 on ≥ 4 days. key exclusion criteria: 1. has a history of chronic pelvic pain that is not caused by endometriosis. 2. has any chronic pain or frequently recurring pain condition, other than endometriosis that is treated with opioids or requires analgesics for ≥ 7 days per month. 3. has had surgical procedures for treatment of endometriosis within the 3 months prior to the screening visit. 4. has a history of or currently has osteoporosis or other metabolic bone disease. 5. has a clinically significant gynecologic condition, other than endometriosis, identified during screening or run-in period transvaginal ultrasound or endometrial biopsy.

Keywords: endometriosis pain dysmenorrhea
inspiratory muscle training and neuromuscular electrical stimulation in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a significant current public health problem, characterized by the presence of limited airflow. however, copd has important manifestations beyond the lungs, the so-called systemic effects. these included dysfunction of peripheral and respiratory muscles. the growing amount of evidence has shown that patients with copd also present important deficits in postural balance and consequently, increased risk of falling. as an essential part of the management of copd, pulmonary rehabilitation (pr) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for copd patients. exercise is the key component of pr, which is composed of exercise assessment and training therapy. currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (imt) and neuromuscular electrical stimulation (nmes). based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with copd, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (imt and/or nmes) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd, in stages ii, iii and iv, according to criteria of the global initiative for copd (gold); * clinically stable, i.e., absence of infections or exacerbations in the last 3 months; * medical team allows patient to exercise * availability of attending the rehabilitation program. exclusion criteria: * unstable primary pathologies (cardiovascular, renal, metabolic, psychiatric); * hemodynamic instability; * nutritional supplementation on the 4 weeks preceding the study; * severe hearing or visual impairment recorded on patient chart or self-referred; * obesity (bmi \> 30 kg/m2); * neurological or musculoskeletal condition that severely limits mobility and postural control, thus making it impossible to carry out the assessments; * electronic devices, such as heart pacemakers and implantable cardioverter defibrillator; * skin injuries and infection where electrodes would be placed; * prior participation in pulmonary rehabilitation programs 3 months previous to the study; * vertigo; * active smoker and/or alcoholic; * neurological impairment or cerebellar lesions; * deficit in cognitive function; * severe vitamin d deficiency; * physically active.
sustained inflation and chest compression vs 3:1 c:v ratio in asphyxiated newborns

Conditions: Cardiac Arrest

Summary: newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-compression to 1-ventilation (3:1 c:v) ratio. however, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence. the international consensus statement advises to use the 3:1 c:v ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. there continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation. this trial will compare if in newborn infants with cardiac arrest in the delivery room does providing cc+si (a new chest compression technique) compared to 3:1 c:v decreases the incidence of mortality at hospital discharge. this will be a multi-centre international cluster randomized trial.


Eligibility criteria:
inclusion criteria: * newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate * newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth * no known major congenital or chromosomal malformation. all newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. the inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future. exclusion criteria: - newborns born outside of study centers and transported to centers after delivery. sex, race, and ethnicity are not part of the exclusion criteria for this trial, and as such it should represent the combined demographics of all centers involved.
does the deep layer of the deep temporalis fascia really exist?

Conditions: Anatomy; Temporal Region Trauma

Summary: it has been widely accepted that a split of the deep temporal fascia occurs approximately 2 to 3 cm above the zygomatic arch, named the superficial and deep layers. the deep layer of the deep temporal fascia lies between superficial temporal fat pad and the temporal muscle. however, during the investigators' previous surgeries, the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle. this study was conducted to clarify the presence or absence of the deep layer of the deep temporal fascia. and the investigators' clinical study has confirmed the absence of the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle.

the anatomic layers of soft tissues of the temporal region, with regard to the deep temporalis fascia, was investigated in 169 cases operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach from june 2013 to june 2017. among 167 surgeries, this so-called "deep layer of the deep temporalis fascia" was not observed. in fact, the superficial temporal fat pad is closely attached to temporal muscle above the zygomatic arch.

Eligibility criteria:
inclusion criteria: clinical and imaging diagnosis of zygomaticofacial or craniofacial fractures a need to operate using the supratemporalis approach no previously surgical treatment exclusion criteria: unobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region

Keywords: deep temporal fascia deep layer of the deep temporal fascia superficial layer of the deep temporal fascia temporal fascial layers temporal anatomy
efficacy of continuous subcutaneous insulin infusion versus basal-bolus multiple daily injections regimen in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: a lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. in such cases, continuous subcutaneous insulin infusion (csii), using an external pump, could be a solution to improve diabetes control. the aim of this study is to compare, over a one-year period, the efficacy of csii (with aspart insulin) and basal-bolus multiple daily injections (mdi) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (hba1c\>7 -10%).

visit 1: patient information and eligibility criteria assessment visit 2: inform consent signature and randomisation (group csii or mdi). patients randomised in the csii group are instructed to use pump between v2 and v3. visit 3: 5-day's hospitalisation. start of csii or mdi treatments. stop of all oral diabetic medications except for metformin, which is followed up until the end of the study. teaching program on diabetes management (diet, physical activity and self-adjustment of insulin doses). hba1c, clinical and biological parameters. questionnaires. follow-up visits 4-7 (1, 3, 6, 9 months): hba1c. treatment adjustment. adverse events collection. final visit (12 months): hba1c, clinical and biological parameters. questionnaires. adverse events collection.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age \> 18 years * patients treated for at least 6 months by multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection -glargine or detemir- or at least 2 nph insulin injections) plus mealtimes rapid acting insulin injections (human or analogs) +/- oral hypoglycemic agents. * 7,5% ≤ hba1c ≤ 10% * patients able to perform self-monitoring blood glucose (smbg) measurement and insulin injections. * smbg \> 3/day exclusion criteria: * diabetic retinopathy contraindicating glycemic control intensification * situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency...) * situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, ...) * recent (\<3 month) serious pathology * planned treatment or therapy able to induce long-term glycemic control worsening * long lasting (\> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol * pregnancy wish or ongoing pregnancy * known haemoglobinopathy. * creatinin clearance \<30ml/min (mdrd formula). * organ transplant.

Keywords: type 2 diabetes mellitus continuous subcutaneous insulin infusion insulin external pump multiple daily injections basal-bolus regimen education
acetaminophen adduct formation in non-drinkers taking therapeutic doses of acetaminophen for ten consecutive days

Conditions: Drug Induced Liver Injury

Summary: acetaminophen is commonly used to treat fever or pain. your body clears acetaminophen by processing it in the liver. during the processing, some of the acetaminophen may bind to proteins in the liver. the protein-acetaminophen product is called an "adduct." after a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. however, we have found that lower levels may be formed even when people take recommended doses. the purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.


Eligibility criteria:
inclusion criteria: 1. age 21 years or older 2. provide written informed consent 3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers exclusion criteria: 1. history of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment 2. currently taking isoniazid 3. consumption of any alcoholic beverage during the run-in period 4. a detectable serum acetaminophen at baseline 5. serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels greater than 50 iu/l at the start of the run-in period or at baseline 6. platelet count less than 125,000/cc at baseline 7. positive pregnancy test at baseline (female participants only) 8. currently adheres to a fasting type diet as determined by self report 9. currently has anorexia nervosa as determined by self report 10. subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason 11. known hypersensitivity to acetaminophen

Keywords: acetaminophen protein adducts hepatic function drug safety non drinkers